12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including Tuberculosis (TB) and C. difficile, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. This includes known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease